A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir (ALISA)

This study has been withdrawn prior to enrollment.

(drug procurement issues)

Sponsor:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

ClinicalTrials.gov Identifier:

NCT01255371

First Posted: December 7, 2010

Last Update Posted: November 8, 2012

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In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.

This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.

Proportion of adverse events related to antiretroviral treatment, proportion of treatement discontinuations due to antiretroviral side effect, variation of biological parameters and metabolic markers between second line antiretroviral initiation and 24/48 weeks.

Evaluation of second line antiretroviral regimen including boosted lopinavir

Experimental: Arm B : Atazanavir

Lamivudine/tenofovir :

3TC300mg/TDF300mg (Fixed Dose Combination)

1 tablet per day

Atazanavir/ritonavir :

ATV300mg/RTV100mg

2 tablets once a day

Drug: Atazanavir

Evaluation of second line antiretroviral regimen including boosted atazanavir

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

age 18 and above

out patient

documented HIV-1 infection

first line treatment failure:

after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors

two measurements of plasma HIV RNA levels > 1000 copies/mL after at least 6 months of uninterrupted treatment or without any major modification

satisfactory compliance (>80%) to 1st line antiretroviral treatment

signed informed consent

agreement for contraception for women of childbearing age

Exclusion Criteria:

HIV-2 infection or HIV-1/HIV-2 coinfection

uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active TB

first line antiretroviral treatment with a protease inhibitor or tenofovir